Cardiol Res

Cardiology Research, ISSN 1923-2829 print, 1923-2837 online, Open Access

Article copyright, the authors; Journal compilation copyright, Cardiol Res and Elmer Press Inc

Journal website https://cr.elmerpub.com

Original Article

Volume 17, Number 2, April 2026, pages 72-81

Integrating Findings Into Practice: Assessing External Validity of Congestive Heart Failure Trials

↓ Figure 2. Trends in clinical utility, transparency values, and total usefulness of randomized controlled trials (RCTs) on congestive heart failure (CHF) by year of publication. Panels (a)–(c) display the distribution of summed values for clinical utility criteria (a), transparency criteria (b), and total usefulness (c) across publication years. Each dot represents an individual RCT. Red dashed lines represent fitted linear regression lines.

↓ Figure 3. Each point represents a randomized controlled trial (RCT) assessing interventions in congestive heart failure (CHF). The red dashed line indicates a fitted linear regression. A positive, statistically significant correlation was observed between transparency and clinical utility values (Pearson’s r = 0.42, 95% CI: 0.14–0.64, t(42) = 3.03, P = 0.004).

↓ **Table 1.** Usefulness Criteria Item Descriptions
Clinical utility item	Description
1. Problem base	Health impact depends on prevalence, individual burden, and cost, including common and rare diseases.
2. Context placement	Clinical research is most useful when informed by systematic reviews that integrate new findings with existing evidence.
3. Information gain	Informative clinical research requires adequately powered studies focused on critical outcomes, avoiding surrogate measures, and integrating results with prior evidence for meaningful practice changes.
4. Pragmatism	Pragmatic research evaluates the real-world effectiveness of interventions, emphasizing generalizability and practicality over controlled, ideal conditions.
5. Patient-centeredness	Patient-centered research prioritizes questions and outcomes that matter most to patients, involving them in setting priorities and developing core outcomes.
6. Value for money	Value-for-money research evaluates the expected benefits of a study against its costs, using analyses like value-of-information and budget impact to guide design and funding decisions.
7. Feasibility	Feasibility in research depends on realistic recruitment goals, adequate power, and collaborative networks to overcome challenges like patient availability and overestimated sample sizes.
Transparency item	Description
8A. Preregistration	Preregistration is the process of registering a study in an official registry database before recruiting the first patient.
8B. Public protocol	The protocol and data analysis plan should be publicly available before the trial starts and before data analysis.
8C. Protocol adherence	Any deviations from the original protocol should be justified, updated in the protocol, and reapproved by the ethics committee, with modification statements included in the manuscript.
8D. Funding statement	Funding sources for trial conduction should be clearly stated.
8E. Conflict of interest statement	Conflicts of interest should be clearly and completely disclosed.
8F. Data availability	Freely available raw data, including statistical code and output, is becoming the norm to ensure transparency, facilitate meta-analyses, and address concerns about study trustworthiness.

↓ Table 1. Usefulness Criteria Item Descriptions

Clinical utility item

Description

1. Problem base

Health impact depends on prevalence, individual burden, and cost, including common and rare diseases.

2. Context placement

Clinical research is most useful when informed by systematic reviews that integrate new findings with existing evidence.

3. Information gain

Informative clinical research requires adequately powered studies focused on critical outcomes, avoiding surrogate measures, and integrating results with prior evidence for meaningful practice changes.

4. Pragmatism

Pragmatic research evaluates the real-world effectiveness of interventions, emphasizing generalizability and practicality over controlled, ideal conditions.

5. Patient-centeredness

Patient-centered research prioritizes questions and outcomes that matter most to patients, involving them in setting priorities and developing core outcomes.

6. Value for money

Value-for-money research evaluates the expected benefits of a study against its costs, using analyses like value-of-information and budget impact to guide design and funding decisions.

7. Feasibility

Feasibility in research depends on realistic recruitment goals, adequate power, and collaborative networks to overcome challenges like patient availability and overestimated sample sizes.

Transparency item

Description

8A. Preregistration

Preregistration is the process of registering a study in an official registry database before recruiting the first patient.

8B. Public protocol

The protocol and data analysis plan should be publicly available before the trial starts and before data analysis.

8C. Protocol adherence

Any deviations from the original protocol should be justified, updated in the protocol, and reapproved by the ethics committee, with modification statements included in the manuscript.

8D. Funding statement

Funding sources for trial conduction should be clearly stated.

8E. Conflict of interest statement

Conflicts of interest should be clearly and completely disclosed.

8F. Data availability

Freely available raw data, including statistical code and output, is becoming the norm to ensure transparency, facilitate meta-analyses, and address concerns about study trustworthiness.

↓ **Table 2.** Criteria Findings
Clinical utility criteria	N = 44	Transparency criteria	N = 44
Problem base, n (%)		Preregistration, n (%)
Full	4 (9.1)	Full	18 (40.9)
Partial	25 (56.8)	Partial	9 (20.5)
Absent	15 (34.1)	Absent	17 (38.6)
Context placement, n (%)		Public protocol, n (%)
Full	16 (36.4)	Full	6 (13.6)
Partial	28 (63.6)	Partial	7 (15.9)
Absent	0 (0.0)	Absent	31 (70.5)
Information gain, n (%)		Adherence to protocol, n (%)
Full	7 (15.9)	Full	12 (27.3)
Partial	4 (9.1)	Partial	0 (0.0)
Absent	33 (75.0)	Absent	32 (72.7)
Pragmatism, n (%)		Funding stated, n (%)
Full	2 (4.5)	Full	34 (77.3)
Partial	3 (6.8)	Partial	0 (0.0)
Absent	39 (88.6)	Absent	10 (22.7)
Patient centeredness, n (%)		COIs, n (%)
Full	24 (54.5)	Full	30 (68.2)
Partial	6 (13.6)	Partial	2 (4.5)
Absent	14 (31.8)	Absent	12 (27.3)
Value for money, n (%)		Raw data, n (%)
Full	1 (2.3)	Full	6 (13.6)
Partial	1 (2.3)	Partial	4 (9.1)
Absent	42 (95.5)	Absent	34 (77.3)
Feasibility, n (%)
Full	17 (38.6)
Partial	3 (6.8)
Absent	24 (54.5)

↓ Table 2. Criteria Findings

Clinical utility criteria

N = 44

Transparency criteria

N = 44

Problem base, n (%)

Preregistration, n (%)

Full

4 (9.1)

Full

18 (40.9)

Partial

25 (56.8)

Partial

9 (20.5)

Absent

15 (34.1)

Absent

17 (38.6)

Context placement, n (%)

Public protocol, n (%)

Full

16 (36.4)

Full

6 (13.6)

Partial

28 (63.6)

Partial

7 (15.9)

Absent

0 (0.0)

Absent

31 (70.5)

Information gain, n (%)

Adherence to protocol, n (%)

Full

7 (15.9)

Full

12 (27.3)

Partial

4 (9.1)

Partial

0 (0.0)

Absent

33 (75.0)

Absent

32 (72.7)

Pragmatism, n (%)

Funding stated, n (%)

Full

2 (4.5)

Full

34 (77.3)

Partial

3 (6.8)

Partial

0 (0.0)

Absent

39 (88.6)

Absent

10 (22.7)

Patient centeredness, n (%)

COIs, n (%)

Full

24 (54.5)

Full

30 (68.2)

Partial

6 (13.6)

Partial

2 (4.5)

Absent

14 (31.8)

Absent

12 (27.3)

Value for money, n (%)

Raw data, n (%)

Full

1 (2.3)

Full

6 (13.6)

Partial

1 (2.3)

Partial

4 (9.1)

Absent

42 (95.5)

Absent

34 (77.3)

Feasibility, n (%)

Full

17 (38.6)

Partial

3 (6.8)

Absent

24 (54.5)

↓ **Table 3.** Systematic Review Inclusion, Feasibility, and Pragmatism in Clinical Trials
Characteristic	N = 44
^aMultiple studies had more than one pragmatism violation, resulting in a total N = 65 for this section.
Prior systematic review, n (%)
Not cited or performed	26 (59.1)
Systematic review cited	18 (40.9)
Non-feasibility reason, n (%)
No reason provided	20 (45.5)
Study was feasible	18 (40.9)
Attrition	3 (6.8)
Low recruitment speed	3 (6.8)
Pragmatism violation^a, n (%)
Blinding of assessors	22 (50.0)
Placebo-controlled	18 (40.9)
Employs a new intervention	12 (27.3)
Single-centered trial	9 (20.5)
No pragmatism violation	3 (6.8)
Employs a new indication	1 (2.3)

↓ Table 3. Systematic Review Inclusion, Feasibility, and Pragmatism in Clinical Trials

Characteristic

N = 44

^aMultiple studies had more than one pragmatism violation, resulting in a total N = 65 for this section.

Prior systematic review, n (%)

Not cited or performed

26 (59.1)

Systematic review cited

18 (40.9)

Non-feasibility reason, n (%)

No reason provided

20 (45.5)

Study was feasible

18 (40.9)

Attrition

3 (6.8)

Low recruitment speed

3 (6.8)

Pragmatism violation^a, n (%)

Blinding of assessors

22 (50.0)

Placebo-controlled

18 (40.9)

Employs a new intervention

12 (27.3)

Single-centered trial

9 (20.5)

No pragmatism violation

3 (6.8)

Employs a new indication

1 (2.3)